Product Information for the User

Rizatriptan Sandoz 10 mg Bucodispersible Tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

1.What Rizatriptan Sandoz is and what it is used for

2.What you need to know before you start taking Rizatriptan Sandoz

3.How to take Rizatriptan Sandoz

4.Possible side effects

5.Storage of Rizatriptan Sandoz

6.Contents of the pack and additional information

Rizatriptán Sandoz containsthe active ingredient rizatriptan, which belongs to a group of medicines called selective serotonin receptor agonists 5-HT1B/1D.

Rizatriptan is used to treat headaches caused by migraine attacks in adults.

Do not take Rizatriptán Sandoz if:

• You are allergic to rizatriptan or to any of the other ingredients of this medication (including those listed in section 6),
• You are currently taking monoamine oxidase inhibitors (MAO) such as moclobemide, phenelzine, tranylcypromine (used to treat depression) or linezolid (a medication used to treat bacterial infections) or if it has been less than two weeks since you stopped taking an MAO inhibitor (see section“Taking Rizatriptán Sandoz with other medications”),
• You have severely damaged renal or hepatic function,
• You have had a previous stroke or symptoms similar to a stroke that disappeared after one or two days (transient ischemic attack, TIA),
• You have severe, moderate, or mild hypertension that is not controlled with medication,
• You have had a heart disease (poor blood circulation in the heart arteries), a heart attack, or a specific type of chest pain known as Prinzmetal's angina,
• You have had problems with blood circulation in the legs (peripheral vascular disease),
• You are taking another medication for migraine such as ergotamine, medications of the ergotamine type (dihydroergotamine, methysergide) or other medications of the same class (i.e., 5-HT1B/1Dreceptor agonists, such as sumatriptan, naratriptan, or zolmitriptan) (see section“Taking Rizatriptán Sandoz with other medications”).

Warnings and precautions

Consult your doctor or pharmacistbefore starting to take Rizatriptán Sandoz if you have:

• Any of the following risk factors for heart disease:

-high blood pressure or diabetes,

-you are a smoker or are taking nicotine substitutes,

• Family history of heart disease,
• You are a man over 40 years old or a postmenopausal woman,
• You have kidney or liver problems,
• You have a specific heart rhythm problem (blockage of a branch),
• You have had an allergy,
• You have had headaches associated with dizziness, difficulty walking, lack of coordination, or weakness in legs and arms,
• You have had allergic reactions such as swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing caused by this medication or similar ones (angioedema),
• You have had transient symptoms including chest pain and pressure.

If you take rizatriptan frequently, it may cause chronic headache. In such cases, you must contact your doctor immediately and stop taking these tablets.

Please inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have migraines.You should only take rizatriptan for a migraine attack.Rizatriptan should not be used to treat other headaches that may be caused by more serious diseases.

If you are over 65 years old, your doctor will advise you on whether you can take these tablets.

Children and adolescents

Rizatriptan is not recommended for use in children under 18 years of age.

Other medications and Rizatriptán Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take rizatriptan with:

Monoamine oxidase inhibitors (MAO)such as moclobemide, phenelzine, linezolid, or tranylcypromine, or if it has been less than two weeks since you stopped taking an MAO inhibitor.

Some medications for migraine,for example,

• Other medications of the same family as rizatriptan, such as sumatriptan, naratriptan, or zolmitriptan,
• Medications of the ergotamine type, such as ergotamine, dihydroergotamine, or methysergide. After taking rizatriptan, wait at least 6 hours before taking these medications and wait at least 24 hours before starting to take rizatriptan after finishing the medication of the ergotamine type.

Ask your doctor for instructions on how to take rizatriptan, and information on the risks if you are also taking:

• Antidepressants such as sertraline, escitalopram, fluoxetine, venlafaxine, and duloxetine,
• Propranolol (usually used to treat high blood pressure) - you should only take the lower dose of 5 mg of rizatriptan,
• A herbal remedy based on St. John's Wort (Hypericum perforatum). Taking it with rizatriptan may increase the likelihood of adverse effects. It is recommended not to take them together.

Taking Rizatriptán Sandoz with food

It is best to take these tablets on an empty stomach, but you can also take them after eating. If you take rizatriptan with food, it may take longer to take effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The available data on the safety of rizatriptan when used during the first three months of pregnancy do not indicate an increased risk of birth defects.

The safety of rizatriptan for the fetus when taken by a pregnant woman after the first three months of pregnancy is unknown.

If you are breastfeeding, you can postpone breastfeeding for 12 hours after treatment to avoid exposing the baby.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Migraine or treatment with rizatriptan may cause drowsiness in some patients. Dizziness has also been observed in some patients taking this medication. If you experience these effects, you should check your ability to drive or operate machinery safely.

Rizatriptán Sandoz contains aspartame, sodium, and sulfites

This medication contains 5.6 mg of aspartame in each buccal tablet.Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains less than 23 mg of sodium (1 mmol) perbuccal tablet; this is essentially “sodium-free”.

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of choking) because it contains sulfites.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Rizatriptan is not used to prevent migraine. It only acts when the crisis has started.

The usual recommended dose for adults over 18 years oldis 10 mg at the first symptoms of a migraine crisis. However, in some patients the recommended dose is 5 mg. Your doctor will decide your appropriate dose and it is important that you take the medication as your doctor has indicated.

Most migraine crises are alleviated with a single dose (one tablet) of rizatriptan, but in the case that you do not notice relief in the same after taking a tablet, DO NOT take another tablet to treat the same migraine crisis and seek medical advice.

Even if a migraine crisis does not alleviate with the intake of rizatriptan, it is still likely that in the next migraine crisis you will obtain a response to the medication.

If you have ANOTHER migraine crisis within 24 hours after the first one, you can take another tablet of Rizatriptan Sandoz, but do not take more than two tablets in a 24-hour period. Always wait at least 2 hours between each dose.

Administration form

Take the buccal tablets in the following way:

1. Separate the blister following the perforated line.
2. Pull the tab of the blister carefully from the arrow, as indicated by the drawing.

Place the tablet on the tongue to dissolve and swallow it with saliva. You do not need to drink water to swallow the tablet.

If you take more Rizatriptan Sandoz than you should

It is important to follow the doses that your doctor has prescribed. If you have taken more tablets than your doctor has prescribed, you must seek immediate medical attention as an overdose of tablets can harm you. The effects caused by taking an overdose of tablets may include effects similar to those described in section 4, especially: dizziness, drowsiness, fainting, and slowing of heartbeats. You may also experience an increase in blood pressure and adverse effects that affect the heart and circulation.

If you have taken more Rizatriptan Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you have any other doubt about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

In adult clinical trials, the most frequently reported side effects were dizziness, somnolence, and fatigue.

Inform your doctor immediately if you experience symptoms of allergic reactions, serotonin syndrome, a heart attack, or a stroke:

• severe allergic reactions, including swelling of the face, lips, tongue, and throat that may cause difficulty breathing, speaking, or swallowing (angioedema),
• severe allergic reaction with rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, and fever,
• chest pain, chest tightness, or throat tightness, or other symptoms associated with a heart attack,
• weakness or paralysis of the limbs or face, difficulty speaking that may indicate a stroke,
• a condition called "serotonin syndrome" characterized by coma, unstable blood pressure, extremely high body temperature, muscle coordination problems, agitation, and hallucinations.

Side effects

Frequent(may affect up to 1 in 10 people):

• dizziness, somnolence, and feeling weak or fatigued,
• headache, tingling sensation (paresthesia), decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia,
• rapid and irregular heartbeat (palpitations),
• throat discomfort,
• nausea (feeling unwell), dry mouth, vomiting, diarrhea, indigestion,
• flushing (temporary redness of the face),
• sensation of heaviness in some parts of the body, neck pain, stiffness,
• stomach or chest pain.

Infrequent(may affect up to 1 in 100 people):

• muscle coordination problems, disorientation, nervousness, sensation of spinning,
• shaking,
• syncope,
• altered sense of taste,
• blurred vision,
• high blood pressure,
• angina,
• difficulty breathing,
• thirst,
• rash, itching, and rash, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing and/or swallowing (angioedema),
• sweating,
• sensation of tension in the body, muscle weakness,
• irregular heartbeat, abnormal ECG (electrocardiogram) findings,
• facial pain, muscle pain.

Rare(may affect up to 1 in 1,000 people):

• asthma,
• allergic reaction (hypersensitivity); potentially fatal anaphylactic reaction,
• stroke (this usually occurs in patients with risk factors for heart and blood vessel disease (hypertension, diabetes, smoking, nicotine replacement therapy, family history of heart disease or stroke, men over 40 years old, postmenopausal women, particularly problems with heart rhythm [branch block]),
• slow heartbeat.

Unknown frequency(cannot be estimated from available data):

• spasms of blood vessels in the limbs, including coldness and numbness of the hands or feet,
• seizures,
• a condition called "serotonin syndrome" that may cause reactions such as coma, unstable blood pressure, extremely high body temperature, muscle coordination problems, agitation, and hallucinations,
• severe skin peeling with or without fever (toxic epidermal necrolysis),
• ischemic colitis (inflammation causing abdominal pain or diarrhea),
• heart attack or coronary artery spasm. This usually occurs in patients with risk factors for heart and blood vessel disease. The risk factors are high blood pressure, diabetes, smoking, nicotine replacement therapy, family history of heart disease or stroke, men over 40 years old, postmenopausal women, particularly problems with heart rhythm (branch block).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Rizatriptan Sandoz

The active ingredient is rizatriptan. Each buccal dispersible tablet contains 10 mg of rizatriptan (as benzoate).

The other components are: calcium silicate, crospovidone type A, anhydrous colloidal silica, microcrystalline cellulose silicified, manitol (E 421), aspartamo (E 951), magnesium stearate, sweet orange flavoring (contains gum arabic (E 414), ascorbic acid (E 300), ethyl butyrate, maltodextrin, orange oil, propylene glycol (E 1520), sodium, sulfites).

Appearance of the product and contents of the package

Buccal dispersible tablet.

White to light gray, round, flat tablets marked with “RZT” on one side and “10” on the other.

The buccal dispersible tablets are packaged in aluminum/aluminum blisters that are presented inside a cardboard package.

Package sizes: 2, 3, 6, 12, 18 buccal dispersible tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

Lek Pharmaceuticals, d.d.

Verovškova 57

1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals, d.d.

Trimlini 2D

9220 Lendava

Slovenia

or

LEK S.A.

Ul. Podlipie 16

95-010 Stryków

Poland

or

Lek, S.A.

Ul Domaniewska 50 C

PL02-672 Warsaw

Poland

or

SANDOZ

SRL Livezeni Street, 7A

RO-540472 Targu Mures

Romania

or

Salutas Pharma GmbH

Otto Von Guericke Alle, 1

D-39179 Barleben

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark: Rizatriptan Sandoz

Germany: Rizatriptan lingual – 1 A Pharma 10 mg Schmelztabletten

Italy: RIZATRIPTAN SANDOZ 10 mg compresse orodispersibili

Netherlands: Rizatriptan Sandoz 10 mg, orodispergeerbare tabletten

Slovakia: Rizatriptan Sandoz 10 mg orodispergovatelné tablety

Spain: Rizatriptán Sandoz 10 mg comprimidos bucodispersables EFG

Sweden: Rizatriptan Sandoz 10 mg munsönderfallande tablett

United Kingdom: Rizatriptan 10 mg Orodispersible Tablets

Last review date of this prospectus:July 2024.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/